Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population

Summary

Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that expand criteria currently used by Center for Medicare \& Medicaid Services (CMS), and 2) to assess the correlation between measures of speech recognition in candidates for cochlear implants and their utility in predicting audiologic and quality of life outcomes after implantation.

Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical insurance coverage.

Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in a patient population that does not meet current CMS candidacy criteria.

Conditions

• Bilateral Sensorineural Hearing Loss

Interventions

DEVICE

Cochlear implant

A cochlear implant consists of an implantable device that electrically stimulates surviving nerve fibers within the inner ear to produce perceptions of sound in patients with significant sensorineural hearing loss.. The implanted device is controlled by an external sound processor that converts acoustic sound signals into patterns of electrical stimulation that result in sound perception for the user.

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Miami

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Loyola University Chicago

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Saint Luke's Health System

  collaborator OTHER

• Massachusetts Eye and Ear Infirmary

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Rocky Mountain Ear Center Audiology and Ear Services

  collaborator UNKNOWN

• American Cochlear Implant Alliance

  lead OTHER

Principal Investigators

• Teresa A Zwolan, Ph.D · University of Michigan & American Cochlear Implant Alliance

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• United States

Study Locations